Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

PHASE3CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Behavioral Variant Frontotemporal Dementia (bvFTD)
Interventions
DRUG

TRx0237

TRx0237 100 mg tablet will be administered twice daily.

DRUG

Placebo

Placebo tablets will be administered twice daily. The placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.

Trial Locations (67)

1081

Alzheimer Research Center Amsterdam, Amsterdam

2031

Neuroscience Research Australia, Randwick

3015

Erasmus University Medical Center, Rotterdam

3128

Box Hill Hospital, Box Hill

5223

Jeroen Bosch Ziekenhuis, afdeling geriatrie, 's-Hertogenbosch

6005

Neurodegenerative Disorders Research Pty Ltd, West Perth

10000

University Hospital Centre Zagreb, Zagreb

10090

University Psychiatric Hospital Vrapče, Zagreb

10117

Charité-Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Berlin

10126

Neurology I, Department of Neuroscience, University of Torino, Torino

11229

Integrative Clinical Trials LLC, Brooklyn

12208

Neurological Associates of Albany, P. C., Albany

13125

Memory Clinic, ECRC, Berlin

19046

The Clinical Trial Center, LLC, Jenkintown

19104

Hospital of the University of Pennsylvania, Department of Neurology, Philadelphia

20133

"Fondazione IRCCS Istituto Neurologico Carlo Besta", Milan

20246

Universitätsklinikum Hamburg-Eppendorf Klinik für Psychiatrie und Psychotherapie, Hamburg

21224

Johns Hopkins University, Baltimore

22903

University of Virginia, Charlottesville

25125

Unità di Neuroimmagine e Epidemiologia Alzheimer, Brescia

27599

UNC Department of Neurology, Physicians Office Building, Chapel Hill

30329

Department of Neurology, Emory University, Atlanta

32224

Mayo Clinic, Jacksonville

32806

Compass Research, LLC, Orlando

33613

University of South Florida, Tampa

34601

Meridien Research, Brooksville

44106

University Hospitals Case Medical Center, Neurology Clinical Trials Unit, Cleveland

46202

Indiana University Department of Neurology, Indianapolis

50012

Hospital Viamed Montecanal, Neurology Department, Zaragoza

51003

Ceuta University Hospital; Neurology, Ceuta

55905

Mayo Clinic, Department of Neurology, Rochester

60007

Alexian Brothers Neurosciences Institute Clinical Research, Elk Grove Village

66100

Fondazione Universita' Gabriele D'Annunzio di Chieti, Chieti Scalo

73112

Rivers Wellness and Research Institute, Oklahoma City

81675

Klinik und Poliklinik für Psychiatrie und Psychotherapie der Technischen Universität München, München

84106

PRA Health Sciences, Phase 2/3 Outpatient and CNS Clinic, Salt Lake City

89081

Universitäts - und Rehabilitationskliniken Ulm, Neurologie, Ulm

90095

David Geffen School of Medicine at UCLA, UCLA Neurological Services, Los Angeles

92663

The Shankle Clinic, Newport Beach

94158

Memory and Aging Centre, San Francisco

308433

National Neuroscience Institute Department of Neurology, Singapore

02114

Neurological Clinical Research Institute (NCRI) Massachusetts General Hospital, Boston

07724

Memory Enhancement Center of America, Inc., Eatontown

05201

The Memory Clinic, Bennington

T2N 4Z6

Heritage Medical Research Clinic-University of Calgary, Calgary

V6T 2B5

University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders, Vancouver

V8R 1J8

Vancouver Island Health Authority, Victoria

B3S 1M7

True North Clinical Research, Halifax

N6C 0A7

Geriatric Clinical Trials Group, Parkwood Institute, London

M3B 2S7

Toronto Memory Program, Toronto

M5T 2S8

University Health Network, Toronto Western Hospital, Memory Clinic, Toronto

H4H 1R3

McGill Centre for Studies in Aging, Alzheimer Disease Research Unit, Verdun

61-853

NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska, Poznan

70-111

Euromedis Sp. z o.o., Szczecin

024072

Psychomedical Consult, Bucharest

08028

Fundació ACE. Institut Català de Neurociències Aplicades, Barcelona

AB25 2ZH

NHS Grampian, OAP Directorate, Aberdeen

B15 2FG

The Barberry Out-Patients Department, Birmingham

GL53 9DZ

2gether NHS foundation trust, Cheltenham

DE22 3LZ

Kingsway Hospital, Derby

CM16 6TN

St Margaret's Hospital Mental Health Unit, Epping

W1G 9JF

Cognition Health Ltd., London

W6 8RF

Imperial College Healthcare NHS Trust - Charing Cross Hospital, London

WC1N 3BG

Dementia Research Center at Queens Square, London

OX3 9DU

Nuffield Department of Clinical Neurosciences, Oxford

SY3 5DS

Redwoods Centre, Shrewsbury

SO16 6YD

Wessex Neurological Centre, Southampton General Hospital, Southampton

All Listed Sponsors
lead

TauRx Therapeutics Ltd

INDUSTRY

NCT01626378 - Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD) | Biotech Hunter | Biotech Hunter